UMIN-CTR Clinical Trial

Basic information
Public title	Safety and complication of intrahospital transfer in critically ill patients; a systematic review and meta-analysis
Acronym	Safety and complication of intrahospital transfer in critically ill patients; a systematic review and meta-analysis
Scientific Title	Safety and complication of intrahospital transfer in critically ill patients; a systematic review and meta-analysis
Scientific Title:Acronym	Safety and complication of intrahospital transfer in critically ill patients; a systematic review and meta-analysis
Region	Japan

Condition
Condition	Acute respiratory distress syndrome, and severe respiratory or circulatory failure
Classification by specialty	Pneumology Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate and describe the safety and complication of intrahospital transport in critically ill patients.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of adverse events
Key secondary outcomes	Death and serious complications (life-threatening) adverse events The period of of ICU stay The period of of in hospital stay Minor adverse events Costs

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Adults, 18 years old or older 2) Patients with intrahospital transfer during ICU stay 3) patients with ICU admission from other units (emergency department, operation rooms or general wards, etc)
Key exclusion criteria	1) Patients with missing outcomes
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Maki Middle name Last name Murata
Organization	Graduate School of Medicine and Public Health, Kyoto University
Division name	Department of Healthcare Epidemiology
Zip code	606-8501
Address	Yoshida Konoe-cho, Sakyo-ku, Kyoto, Japan
TEL	075-753-4646
Email	murama@muc.biglobe.ne.jp

Public contact
Name of contact person	1st name Maki Middle name Last name Murata
Organization	Graduate School of Medicine and Public Health, Kyoto University
Division name	Department of Healthcare Epidemiology
Zip code	606-8501
Address	Yoshida Konoe-cho, Sakyo-ku, Kyoto, Japan
TEL	075-753-4646
Homepage URL
Email	murama@muc.biglobe.ne.jp

Sponsor
Institute	Department of Healthcare Epidemiology, Graduate School of Medicine and Public Health, Kyoto University
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Graduate School of Medicine and Public Health, Kyoto University
Address	Yoshida Konoe-cho, Sakyo-ku, Kyoto, Japan
Tel	075-753-4646
Email	murama@muc.biglobe.ne.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 Year 07 Month 01 Day

Related information
URL releasing protocol	not released
Publication of results	Published

Result
URL related to results and publications	DOI: 10.1016/j.ajem.2021.11.021
Number of participants that the trial has enrolled	1898
Results	A total of 12,313 intrahospital transports and 1898 patients from 24 studies were included in the meta-analysis. Among 24 studies that evaluated the primary outcome, the pooled frequency of all adverse events was 26.2% (95% CI: 15.0-39.2) and the heterogeneity among these studies was high (I2 = 99.5%). The pooled frequency of death due to intrahospital transport and life-threatening adverse events was 0% and 1.47% each, but heterogeneity was also high.
Results date posted	2022 Year 07 Month 08 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Not applicable due to SR
Participant flow	Not applicable due to SR
Adverse events	Not applicable due to SR
Outcome measures	Not applicable due to SR
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2020 Year 07 Month 01 Day
Date of IRB	2020 Year 05 Month 01 Day
Anticipated trial start date	2020 Year 07 Month 01 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2020 Year 12 Month 15 Day

Other

Other related information

[Database] MEDLINE, CENTRAL, etc Observational studies written in English are included. [Data extraction and management/Assessment of risk of bias] Two review authors will independently extract data from included articles, and assess the risk of bias of them. We will resolve any disagreement through discussion. We will consult a third review author if we disagree each other. [Meta-analysis] We will perform a quantitative analysis when studies are not heterogeneous. Random effects models will be used. [Subgroup analysis] Age/Treatments/The objective of transfers/The type of diseases [Sensitivity analysis] We will assessed the robustness by excluding the studies with high risk of bias.

Management information
Registered date	2020 Year 07 Month 01 Day
Last modified on	2022 Year 07 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046778